Issue link: https://www.e-digitaleditions.com/i/1067339
42 January 2019 Tablets & Capsules FDA releases new gluten labeling guidance The December 2017 FDA draft Guidance for Industry titled "Gluten in Drug Products and Associated Labeling Recommendations" [1] explains the FDA's recommendations on how drug products should be labeled regarding gluten content. The FDA states that the Guidance was developed to address concerns for patients with celiac disease and that its recommendations also apply to patients with other conditions treated with a gluten-free diet. The draft Guidance encourages consistency among manufacturers who label their drug products for the presence of gluten. Standard- i z e d l a b e l i n g s h o u l d i m p r o v e consumer aware- n e s s a n d m i n i - m i z e c o n f u s i o n about the pres- ence of gluten in drug products. The FDA esti- m a t e d t h a t t h e quantities of glu- ten from excipi- ents derived from wheat are low and do not exceed the amounts of gluten that could be found in food products labeled glu- ten-free. The agency is not aware of an oral drug product currently mar- keted in the US that contains wheat flour as an ingredient. The FDA sug- gests that an oral drug product that contains intentionally added wheat flour as an ingredient should be labeled to indicate it. Wheat starch is highly processed, which should remove any significant amount of gluten. Wheat gluten may be found in low concentrations (<20 ppm) as an impurity in ingredients found in food such as wheat starch and, to a lesser extent, in constitu- ents derived from wheat starch and ingredients produced through the fermentation of wheat. The FDA recognizes a risk that very small amounts of wheat gluten may be present in wheat-starch- derived excipients if wheat starch is used as the starting material. This category also includes modified starch, pregelatinized starch, sodium starch glycolate, starch hydrolysates (e.g., maltodextrin, dextrates, dex- trose, maltose, and sugar alcohols such as sorbitol, xylitol, maltitol, and mannitol), which, if derived from wheat, may have been processed to destroy or remove gluten. Starch derivatives are more highly pro- cessed than wheat starch, and the FDA indicated that they may contain gluten at the same or lower concen- trations than may be found in wheat starch. The FDA discussed specific considerations and estimates for how much gluten may be found as an impurity per unit dose of a drug p r o d u c t m a d e with these ingre- d i e n t s . T h e majority of these materials used in pharmaceuticals are derived from corn (maize) or potato starches. The FDA con- cluded that indi- v i d u a l s w h o respond well to a gluten-free diet are at low risk of experiencing problems as a result of the possible presence of gluten in a drug product. Drug product manufacturers are encouraged to have available accu- rate information about their drug product's gluten content, so they can respond to questions from consumers and healthcare professionals. Accord- ing to the FDA, drug manufacturers that wish to make voluntary state- ments about gluten on oral drug product labels or in required labeling should use the following statement: "Contains no ingredient made from a gluten-containing grain (wheat, bar- ley, or rye)." Criteria for "gluten-free" labeling statements for oral drug products have not been established by the Center for Drug Evaluation and Research (CDER). IPEC-Americas comments on FDA new guidance IPEC-Americas submitted com- ments to the docket for the Decem- ber 2017 Guidance and believes that, if drug products formulated with "wheat gluten" as an ingredient exist, they should clearly disclose on the label that "wheat gluten" is an ingredient. With this added labeling requirement, celiac sufferers should have enough information to avoid using a product that may cause an undesirable immune response and use other therapeutically equivalent products instead. The IPEC-Ameri- cas comments submitted to the FDA docket included example calcula- tions estimating the daily gluten consumption level from a hypotheti- cal oral drug product based on worst-case scenarios. On the CDER "Medications and Gluten" webpage, the FDA provides the following information for the types of ingredients that may contain gluten in oral drug products [2]: "The majority of oral drug products either contain no gluten or virtually no gluten. "Based on information available to the Agency, we are aware of no oral drug products currently mar- keted in the United States that con- tain wheat gluten or wheat flour intentionally added as an inactive ingredient. We would expect any such product, if it existed, to include wheat gluten or wheat flour in the list of ingredients in its labeling. "FDA has identified very few oral drugs that contain wheat starch as an ingredient. Starch can also be used as a starting material for manufacturing various ingredi- ents found in oral drugs. Starch used for this purpose is often corn starch or potato starch, not wheat starch. Even if wheat starch were used, either as an ingredient or as a starting material, there would be The FDA concluded that individuals who respond well to a gluten-free diet are at low risk of experiencing problems as a result of the possible presence of gluten in a drug product.